Exploring the Modulatory Effect of the Dialyzer Membrane Choice on Hemodialysisassociated Thromboinflammation: a Prospective Randomized Cross-over Trial

NCT07682701 | Active Not Recruiting

• 1 other identifier: BUN 1432026000041
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial investigates whether the dialyzer membrane influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of 3 commercially available dialyzer membrane types on immune cell activation and thromboinflammatory responses. During this trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialyzer membranes in a crossover design, one for each session with a total study duration of 1 week. During each session blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells. The study aims to:

• Assess whether the dialyzer membrane influences leukocyte and platelet activation .
• Evaluate whether the dialyzer membrane influences neutrophil extracellular trap (NET) formation.
• Evaluate whether the dialyzer membrane influences the transcriptomic profiles of immune cells.

Conditions

Hemodialysis; Hemodialysis Treatment; Thromboinflammation; End Stage Renal Disease (ESRD)

Keywords

hemodialysis; thromboinflammation; dialyzer membrane; neutrophil extracellular traps; thrombin generation

Outcome Measures

Primary Outcomes (1)

• Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition

  The primary endpoint will be the difference in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialyzer membrane used.

  Over the course of 1 week (3 hemodialysis sessions)

Secondary Outcomes (3)

• Differences in leukocyte and platelet activation markers in blood and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition

  over the course of 1 week (3 hemodialysis sessions)

• Differences in coagulation activation and inflammatory markers measured by multiplex-based immunoassays in relation to dialysate composition

  Over the course of 1 week (3 hemodialysis sessions)

• Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition

  Over the course of 1 week (3 hemodialysis sessions)

Study Arms (3)

Polysulfone dialyzer membrane

ACTIVE COMPARATOR

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)

Device: Use of a polysulfone membrane

Asymmetric triacetate dialyzer membrane

ACTIVE COMPARATOR

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)

Device: Use of an asymmetric triacetate membrane

Polymethyl methacrylate dialyzer membrane

ACTIVE COMPARATOR

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)

Device: Use of a polymethyl methacrylate membrane

Interventions

Use of a polysulfone membrane DEVICE

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)

Polysulfone dialyzer membrane

Use of an asymmetric triacetate membrane DEVICE

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)

Asymmetric triacetate dialyzer membrane

Use of a polymethyl methacrylate membrane DEVICE

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)

Polymethyl methacrylate dialyzer membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dialysis vintage ≥ 3 months
• Treatment schedule of 3x4 hours weekly
• well functioning dual lumen vascular access
• Treatment with ASA 80-100mg daily
• Patients able and agree to provide signed informed consent

You may not qualify if:

• Known vascular access dysfunction defined by FOR CATHETER ACCESS: high dose urokinase use within 4 weeks prior to study participation, planned catheter opacification, Qb \<250mL/min within the 2 weeks prior to study participation FOR AV ACCESS: planned AV access intervention, recent AV access intervention within 4 weeks prior to study participation, known AV access dysfunction
• Known active malignancy and/or active autoimmune disease
• Known clotting/bleeding disorders
• Current treatment with immunosuppressive medication
• Current treatment with P2Y12 receptor antagonists (including clopidogrel, prasugrel, ticlodipine, cangrelor, ticagrelor), epoprostenol and glycoproteine IIb/IIIa receptor antagonists (tirofiban)
• Current treatment with oral anticoagulation maintenance therapy, including vitamin K antagonists or direct oral anticoagulants
• Current treatment with low molecular weight heparins (LMWH), heparinoids, bivalirudin, fondaparinux, protein C, or antithrombin.
• Active infection and/or ongoing systemic antimicrobial treatment.
• Hospitalized patients
• Patients treated with heparin-free hemodialysis
• Recent (\<1 week) platelet transfusion or packed cells transfusion
• Patients receiving intradialytic TPN
• Patients requiring intravenous iron administration during dialysis (EPO or Parsabiv administration will be postponed until after disconnection from the dialysis circuit and after T240 blood sampling).
• Patients with cytopenia affecting either white blood cells (WBC \< 4x10³/mm³) or platelets defined as (platelet counts \<100x10³/mm³)
• Patients known to have had allergic reactions to PS, PMMA or ATA dialyzer

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator
• NIER research group: collaborator
• University of Rochester: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Thromboinflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Inflammation

Study Officials

• Florine Janssens, Medical Doctor

  Universitair Ziekenhuis Brussel (UZ Brussel)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a prospective, randomized, crossover design during which biological samples will be collected during each treatment session (3 in total over the course of 1 week). During each session, the patient will be treated by another dialyzer membrane (polysulphone vs asymmetric triacetate vs polymethyl methacrylate)

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: April 13, 2026
• Primary Completion: May 15, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-05

Locations

BE (1)